Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
NCT ID: NCT00621192
Last Updated: 2023-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2008-06-30
2009-10-31
Brief Summary
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Detailed Description
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The specific aims of this trial are:
1. To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections.
2. To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections.
3. To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Meropenem
These
Participants were subdivided into the following four groups based on Gestational Age (GA) and Postnatal Age (PNA):
Group 1: GA at birth below 32 weeks - PNA \<2 weeks; Group 2: GA at birth below 32 weeks - PNA ≥2 weeks and \<91 days; Group 3: GA at birth 32 weeks or older - PNA \<2 weeks; Group 4: GA at birth 32 weeks or older - PNA ≥2 weeks and \<91 days.
meropenem
Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant.
20 mg/kg every 12 hours in infants \<32 weeks GA and PNA \< 2 weeks 20 mg/kg every 8 hours in infants \<32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA \< 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks
Interventions
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meropenem
Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant.
20 mg/kg every 12 hours in infants \<32 weeks GA and PNA \< 2 weeks 20 mg/kg every 8 hours in infants \<32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA \< 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age younger than 91 days
3. Likely to survive beyond the first 48 hours after enrollment
4. Sufficient intravascular access (either peripheral or central) to receive study drug.
AND ONE OF THE FOLLOWING
5. 1\) Physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection. These include peritonitis, NEC (Necrotizing Enterocolitis) Grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous perforation, meconium ileus with perforation, bowel obstruction with perforation, as evidenced by free peritoneal air on abdominal radiograph, intestinal pneumatosis or portal venous gas on abdominal radiographic examination.
OR 2) Possible NEC OR 3) Otherwise receiving meropenem per local standard of care
Exclusion Criteria
2. Serum creatinine \>1.7 mg/dL
3. History of clinical seizures or EEG (Electroencephalogram) confirmed seizures
4. Concomitant treatment with another carbapenem (ertapenem or imipenem) at the time of informed consent
5. Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
90 Days
ALL
No
Sponsors
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The Emmes Company, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Danny Benjamin, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of Alabama
Birmingham, Alabama, United States
Children's Hospital of Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California Medical Center
San Diego, California, United States
Sharp-Mary Birch Hospital for Women
San Diego, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
Kansas City Children's Mercy Hospital
Kansas City, Missouri, United States
Albany Medical Center
Albany, New York, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Case Western Reserve, RB&C, UHCMC
Cleveland, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah medical Center
Salt Lake City, Utah, United States
Countries
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References
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Cohen-Wolkowiez M, Poindexter B, Bidegain M, Weitkamp JH, Schelonka RL, Randolph DA, Ward RM, Wade K, Valencia G, Burchfield D, Arrieta A, Mehta V, Walsh M, Kantak A, Rasmussen M, Sullivan JE, Finer N, Rich W, Brozanski BS, van den Anker J, Blumer J, Laughon M, Watt KM, Kearns GL, Capparelli EV, Martz K, Berezny K, Benjamin DK Jr, Smith PB; Meropenem Study Team. Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections. Clin Infect Dis. 2012 Dec;55(11):1495-502. doi: 10.1093/cid/cis758. Epub 2012 Sep 5.
Other Identifiers
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HHSN267200700051C
Identifier Type: OTHER
Identifier Source: secondary_id
HHSN267200700051C
Identifier Type: -
Identifier Source: org_study_id
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